Role of Axumin PET Scan in Germ Cell Tumor (TESTPET)
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ClinicalTrials.gov Identifier: NCT03426865 |
Recruitment Status :
Active, not recruiting
First Posted : February 8, 2018
Last Update Posted : December 21, 2022
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Condition or disease | Intervention/treatment |
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Testis Cancer Germ Cell Tumor Testicular Cancer Germ Cell Tumor of Testis Germ Cell Tumor, Testicular, Childhood Testicular Neoplasms Testicular Germ Cell Tumor Testicular Yolk Sac Tumor Testicular Choriocarcinoma Testicular Diseases Germ Cell Cancer Metastatic Germ Cell Neoplasm of Retroperitoneum Germ Cell Cancer, Nos | Drug: Axumin PET scan |
Study Type : | Observational |
Actual Enrollment : | 10 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic Acid (Axumin) Positron Emission Tomography/Computed Tomography Prior to Retroperitoneal Lymph Node Dissection for Testicular Cancer |
Actual Study Start Date : | March 1, 2018 |
Estimated Primary Completion Date : | December 30, 2022 |
Estimated Study Completion Date : | December 30, 2022 |

Group/Cohort | Intervention/treatment |
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Axumin PET scan
Only one arm is being evaluated--the arm receiving PET scan
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Drug: Axumin PET scan
PET scan prior to RPLND
Other Name: PET SCAN ARM |
- Performance characteristics of Axumin PET scan in patients undergoing retroperitoneal lymph node dissection [ Time Frame: Two years ]Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Males with germ cell tumors (testicular cancer) |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients with histologically confirmed NSGCT after orchiectomy who are scheduled to undergo primary RPLND or post-chemotherapy RPLND
- Patients must be over 18 years old and capable and willing to provide informed consent.
- Medically stable as judged by patient's physician.
- Life expectancy must be estimated at > 6 months.
- Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan. Patients will be asked if they have problems or issues with lying flat
Exclusion Criteria:
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to anti-18F-FACBC are NOT eligible.
- Patients with liver failure are NOT eligible.
- Patients currently undergoing chemotherapy or chemotherapy within two weeks of anti-18F-FACBC PET/CT scan are NOT eligible

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426865
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Yair Lotan, MD | University of Texas Southwestern Medical Center |
Responsible Party: | yair lotan, Professor of Urology, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT03426865 |
Other Study ID Numbers: |
STU 032017-051 |
First Posted: | February 8, 2018 Key Record Dates |
Last Update Posted: | December 21, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
retroperitoneal lymph node dissection testicular cancer testis cancer germ cell tumor |
PET scan Axumin teratoma |
Neoplasms Neoplasms, Germ Cell and Embryonal Endodermal Sinus Tumor Choriocarcinoma Testicular Neoplasms Retroperitoneal Neoplasms Testicular Diseases Neoplasms by Histologic Type Mesonephroma Trophoblastic Neoplasms Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Pregnancy Complications, Neoplastic Pregnancy Complications Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Male Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |